RWD SIG

Purpose

To increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.

Objectives

Our objectives include:

  • Facilitate sharing of case studies and experiences in this area
  • Collate and summarise publications, articles, presentations, training
  • Identify emerging news and trends
  • Organise and/or participate in workshops related to RWD
  • Collaborate with key stakeholder groups (EFSPI/PSI, EFPIA, ISPOR,  regulatory and academia)
  • Provide comments on RWD related guidelines, e.g. country-specific methods guidelines, FDA methods guidelines, ISPOR etc.
  • Develop/highlight best practices and recommendations
  • Influence industry practice and acceptance of approaches by regulators and other stakeholders

 

Who we are

NameCompany/Institution
Anny Stari (Co-chair)

GSK

Josephine Wolfram (Co-chair)Astellas
Peter Almgren

LEO Pharma

Anders Berglund 

Daiichi-Sankyo

Tobias Bluhmki 

Bristol Myers Squibb
Miranda Cooper BresMed 
Imi FaghmousKite Gilead
Fiona GrimsonUCB
Randi GrønNovo Nordisk

Alessandro Guasconi 

Chiesi Farmaceutici S.p.A.
Daniel Leibovitz Incyte
Elizabeth MerrallJanssen
Deepak Parashar  

Warwick University

Antonio Remiro-Azocar Bayer
Alexander Schacht Veramed
Claire SmithAstraZeneca
Aijing ShangUCB
Rachel Tham Veramed
Barbara TorlinskaVisible Analytics Ltd. / University of Birmingham

Sudhir Venkatesan

AstraZeneca
Huajun WangGSK

Jixian Wang

Bristol Myers Squibb

Qing Wang 

Roche

Call for members

Frequency of Meetings

Bi-monthly teleconferences

Upcoming Events

PSI VisSIG Wonderful Wednesday Webinar Series

This is a good opportunity to develop your knowledge by thinking through a practical example, practicing how to apply graphics principles, and developing your coding skills.

PSI Pre-Clinical SIG Webinar: Assay Qualification by Linear Mixed Model: Confidence, Prediction & Tolerance Intervals

Dr Francq will discuss the need for analytical methods to deliver unbiased and precise results and talk in detail on confidence, prediction and tolerance intervals work in linear mixed models and the interpretation of statistical results. This will be followed by Q&A.

PSI Training Course: An Interactive Introduction to Agile Ways of Working

During this session you will explore how we best execute change within our roles, build your practical understanding of agile tools and techniques, and inspire you to experiment with the new ways of working to deliver your goals.

PSI EIWG Webinar: Impact of estimands

To understand how the estimand framework changed the development of clinical trials.

PSI Training Course: Hybrid Frequentist / Bayesian Power and Bayesian Power in Planning Clinical Trials

Aimed at Statisticians working on the design of Clinical Trials, participants will learn how to use Expected Power, Average Power, Predicted Power, Probability of Success and Assurance, and Bayesian Power when planning clinical trials.

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